The Evotec subsidiary will develop monoclonal antibodies (mAbs) in a bid to advance the US response to biologics medical countermeasures (MCMs).
Under the program, the firm will focus on decreasing the time for development, manufacturing and CMC (Chemistry, Manufacturing and Controls)-focused regulatory efforts while producing high quality mAbs. The modalities and diseases targeted under the program have not been identified.
With a target of 100 calendar days, the program will include developing and testing mAbs, while improving efficiencies in cGMP manufacturing and enhancing workflows. Beginning with a DOD-identified MCM antibody sequence, the program will conclude with production of clinical doses. According to the firm, the antibody sequence serves to initiate the testing process and enables the evaluation of the manufacturing system and its components.
BioProcess Insider spoke to Just-Evotec Biologics, about the grant program and its wider implication.
Just-Evotec: The Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND) requires innovative approaches that can accelerate the drug development lifecycle through production and delivery.
Under this prototype project, the United States government is seeking optimized manufacturing platforms and techniques that can be seamlessly incorporated into an integrated emergency response system that covers the entire drug development lifecycle. Innovative manufacturing solutions will support an overall 100-calendar-day target timeline for advancing drug development from pathogen identification through fielding of doses. This is necessary, due to a dynamically changing chemical/bioweapons threat landscape and increasing potential that the war fighter may encounter unanticipated threats in the field.
Further, drug development timelines are historically lengthy, limiting response capabilities in an emergency scenario. The primary objective of this effort is to identify, develop and demonstrate optimized manufacturing platforms/techniques that can enhance the government's rapid response capabilities for biologics MCMs.
Just-Evotec: Activities include developing and testing process development optimization, improving efficiencies in cGMP manufacturing and drug product release, and enhancing operational and resource workflows. The program culminates in testing the optimized system components through rapid response exercises, starting with a DOD-identified MCM antibody sequence, and ending with the manufacturing of clinical doses.
Just-Evotec: Drug development timelines can be lengthy, limiting response capabilities in an emergency scenario. The primary objective of Just’s effort is to identify, develop, and demonstrate optimized manufacturing platforms/techniques that can enhance the government’s rapid response capabilities for biologics MCMs. To meet the accelerated timeline, traditional industry approaches must be streamlined, conducted in parallel, substituted with alternative rapid approaches, and/or eliminated from the overall industry-standard and be consistent with regulatory requirements.
Just-Evotec: Just will use its proprietary molecular design and computational tools to significantly reduce process development time. Just will also enhance our current innovative, hybrid and continuous manufacturing platforms to rapidly supply clinical doses by minimizing development and production time.
Just-Evotec: The high quality, productivity, and most importantly, the safety of the mAbs produced at Just-Evotec Biologics is always our highest priority. Rigorous testing, quality control, quality assurance and adherence to all cGMPs are incorporated into our approach to biologics development and manufacturing, including those in this manufacturing optimization program.
Just-Evotec: Just-Evotec Biologics has collaborated with JPEO-CBRND as a performer on several contracts beginning in 2020. Our collaboration throughout these programs and the new manufacturing optimization program will continue with close scientific, technological, and programmatic interactions between our expert teams to achieve program success and meet program goals and deliverables.
Just-Evotec: We anticipate that this program will have a significant impact on the broader biotherapeutics industry to demonstrate that it is possible to significantly increase the speed to first clinical doses while maintaining high mAb quality, productivity, and safety criteria.
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